cGxP

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Complaint Handling
 

 

The complaint or product surveillance system is THE quality system. This complaint system must demonstrate that it is sensitive to product performance.  Complaint handling and reporting are critical to the manufacturer in terms of product liability and regulatory actions, including recall. cGxP can assist in the following ways:
  • Design/Review Complaint Handling Systems 

  • Medical Device Reporting systems (MDR regulations)

  • Design/Review Failure investigation methods and documentation.

  • Develop and implement trending systems for manufacturing and field activity reporting.

  • Company wide systems for collection and analysis of complaint, failure and trend information.

  • Design/Review preventive maintenance incorporated into complaints.

 

 

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